GxP Quality Systems Lead - Biotech

MBX Biosciences, Inc.; Burlington (MA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

MBX Biosciences, Inc. is seeking a Quality Systems & Compliance Specialist to oversee and enhance the Quality Management System, including document control, GxP training, and service provider lifecycle management.

The role ensures regulatory compliance and supports inspections across the organization. The ideal candidate will be detail‑oriented, collaborative, and experienced in regulated biotech environments, with strong organizational and communication skills and a proactive problem‑solver

Qualifications

• Bachelor's degree in a scientific, technical, or related discipline.
• Minimum of 4 years of experience in biotechnology, pharmaceutical, medical device, or other regulated industries.
• Experience managing quality system processes and supporting quality programs.

Responsibilities

• Own and maintain Document Control and GxP Training programs.
• Oversee Service Provider Lifecycle Management and related records.
• Develop and approve quality system procedures and controlled documents.
• Ensure compliance with GMP/GLP/GCP and global regulatory requirements.
• Support internal audits, inspections, and inspection readiness activities.

Education

Bachelor's degree in a scientific/technical discipline

Tools

eQMS

Job description

MBX Biosciences, Inc. is seeking a Quality Systems & Compliance Specialist to oversee and enhance the Quality Management System, including document control, GxP training, and service provider lifecycle management.

The role ensures regulatory compliance and supports inspections across the organization. The ideal candidate will be detail‑oriented, collaborative, and experienced in regulated biotech environments, with strong organizational and communication skills and a proactive problem‑solver